Trial Outcomes & Findings for A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis. (NCT NCT03416985)
NCT ID: NCT03416985
Last Updated: 2019-12-24
Results Overview
plaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Baseline, 1 month
Results posted on
2019-12-24
Participant Flow
Participant milestones
| Measure |
Pulsating Toothbrush
Patients were asked to use a pulsating toothbrush for 30 days Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush
|
Sonic Toothbrush
Patients were asked to use a sonic toothbrush for 30 days
BURST Sonic Oral Care: Electric sonic toothbrush
|
Manual Toothbrush
Patients were asked to use a manual toothbrush for 30 days Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush
|
|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
30
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pulsating Toothbrush
n=28 Participants
Patients were asked to use a pulsating toothbrush for 30 days Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush
|
Sonic Toothbrush
n=30 Participants
Patients were asked to use a sonic toothbrush for 30 days
BURST Sonic Oral Care: Electric sonic toothbrush
|
Manual Toothbrush
n=24 Participants
Patients were asked to use a manual toothbrush for 30 days Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=82 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=28 Participants
|
30 Participants
n=30 Participants
|
24 Participants
n=24 Participants
|
82 Participants
n=82 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=28 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=82 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=28 Participants
|
19 Participants
n=30 Participants
|
14 Participants
n=24 Participants
|
49 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=28 Participants
|
11 Participants
n=30 Participants
|
10 Participants
n=24 Participants
|
33 Participants
n=82 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants
|
30 participants
n=30 Participants
|
24 participants
n=24 Participants
|
82 participants
n=82 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1 monthplaque index as evaluated by Silness-Loe Index: index recording both soft debris and mineralized deposits on teeth (index 0 (no plaque) to 3).
Outcome measures
| Measure |
Pulsating Toothbrush
n=28 Participants
Patients were asked to use a pulsating toothbrush for 30 days Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush
|
Sonic Toothbrush
n=30 Participants
Patients were asked to use a sonic toothbrush for 30 days
BURST Sonic Oral Care: Electric sonic toothbrush
|
Manual Toothbrush
n=24 Participants
Patients were asked to use a manual toothbrush for 30 days Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush
|
|---|---|---|---|
|
Plaque Index
Baseline
|
1.07 units on a scale
Standard Deviation 0.24
|
1.19 units on a scale
Standard Deviation 0.25
|
1.31 units on a scale
Standard Deviation 0.27
|
|
Plaque Index
1 Month
|
1.11 units on a scale
Standard Deviation 0.27
|
1.27 units on a scale
Standard Deviation 0.40
|
1.20 units on a scale
Standard Deviation 0.24
|
PRIMARY outcome
Timeframe: Baseline, 1 monthgingival index as evaluated by Silness-Loe Index, Range 0-3: Score 0 = Normal gingiva. Score 1 = Mild inflammation - slight change in color, slight edema. No bleeding on probing. Score 2 = Moderate inflammation - redness, edema, glazing. Bleeding on probing. Score 3 = Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.
Outcome measures
| Measure |
Pulsating Toothbrush
n=28 Participants
Patients were asked to use a pulsating toothbrush for 30 days Philipps Sonicare DiamondClean 300 Series: Electric pulsating toothbrush
|
Sonic Toothbrush
n=30 Participants
Patients were asked to use a sonic toothbrush for 30 days
BURST Sonic Oral Care: Electric sonic toothbrush
|
Manual Toothbrush
n=24 Participants
Patients were asked to use a manual toothbrush for 30 days Oral B Healthy Clean Manual Toothbrush: Manual Toothbrush
|
|---|---|---|---|
|
Gingival Index
Baseline
|
0.42 units on a scale
Standard Deviation 0.41
|
0.35 units on a scale
Standard Deviation 0.41
|
0.36 units on a scale
Standard Deviation 0.39
|
|
Gingival Index
1 Month
|
0.22 units on a scale
Standard Deviation 0.16
|
0.16 units on a scale
Standard Deviation 0.16
|
0.14 units on a scale
Standard Deviation 0.13
|
Adverse Events
Manual Toothbrush
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sonic Toothbrush
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pulsating Toothbrush
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joan Pi Anfruns, DMD
University of California Los Angeles
Phone: 310-825-0834
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place